C 1 5

UNITED STATES ENVIRONMENTAL PROTECTION AGENCYWASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETYA f TV . A A AND POLLUTION PREVENTIONMs. Mary Anne AuerWexford Labs, Inc.325 Leffmgwell Ave.Kirkwood, MO63122

Subject: Wex-cide Concentrated Germicidal DetergentEPA Registration No.: 34810-8Notification Date: 09/07/2011EPA Receipt Date: 09/07/2011

Dear Ms. Auer,

This letter acknowledges receipt of your notification submitted under the provision ofFIFRA section 3(c)9 and PR Notice 98-10.

Proposed Notification

• Label revisions in response to Agency letter dated 07/22/11

General Comments

Based on a review of the submitted materials, your notification for the label revisions inresponse to Agency letter dated 07/22/11 is acceptable and has been made a part of your file.

Should you have any questions or comments concerning this letter, you may contactme by telephone at (703) 308-6416 or by e-mail at campbell-mcfarlane.jacqueline@epa.gov orJaclyri Carl by telephone at (703) 347-0213 or by e-mail at carl.jaclyn@epa.gov. Whensubmitting information or data in response to this letter, a copy of this letter should accompanythe submission to facilitate processing.

Sincerely,

me Me96U-1

Abduct Manager (34)3gulatory Management Branch II

Antimicrobials Division (751 OP)

ease read instructions on reverse before completing form.( z.

Form Approved. OMB No. 2070-0060

c/EPAUnited States

Environmental Protection AgencyWashington. DC 20460

Registration

Amendment

Other

OPP Identifier Number

Application for Pesticide - Section I

1. Company/Product Number

34810-8

4. Company/Product (Name)Wex-Cide

2. EPA Product ManagerJacqueline McFarlane

PM*34

3. Proposed Classification

yNone Restricted

5. Name and Address of Applicant (Include ZIP Code!

Wexford Labs, Inc.325 Leffingwell AvenueKirkwood, MO 63122

Check if this is a new address

6. Expedited Reveiw. In accordance with FIFRA Section 3(c)(3)(b)(i), my product is similar or identical in composition and labelingto:EPA Reg. No.

Product Name

Section - II

Amendment - Explain below.

Resubmission in response to Agency letter dated.

Notification - Explain below.

Final printed labels in repsonse toAgency letter dated"Me Too" Application.

Other - Explain below.

Explanation: Use additional page(s) if necessary. (For section I and Section II.)

Label revisions in response to Agency letter dated 07/22/2011:-Correct Precautionary statements-Place First Aid statements in text box.-Delet 'recommended" from Farm pPemise directions-Add "pre-clean surfaced prior to disinfection" to all directions-Delete "or" under personal protection for HIV-1

Section - III

1. Material Thw Product Will Ba Packaged In:

Child-Resistant Packaging

Yes

No

* Certification mustbe submitted

Unit Packaging

X _ j Y a s

No

ui n >. i i

HIf "Yes-Unit Packaging wgt.3983 grams

No. percontainer

Water Soluble Packaging

Yes

~K No

If "Yes"Package wgt

No. percontainer

2. Type of Container

MetalPlasticGlassPaperOther (Specify)

3. Location of Net Contents Information

X Label j Container

4. Size(s) Retail Container

12"Hx5.75"W5. Location of Label Directions

[__] On the bottle

6. Manner in Which Label is Affixed to Product LithographPaper gluedStenciled

[ x| Other silk-screened on the bottle

Section - IV

1. Contact Point (Complete items directly below for identification of individual to be contacted, if necessary, to process this application.!

Name

Mary Anne AuerTitle

CEOTelephone No. (Include Area Code)

314-966-4134

CertificationI certify that the statements I have made on this form and all attachments thereto are true, accurate and complete.I acknowledge that any knowlinglty false or misleading statement may be punishable by fine or imprisonment orboth under applicable law.

2. Signature

4. Typed Name

Mary Anne Auer

3. Tide

CEO

S. Data

09/07/2011

6. Data ApplicationReceived

(Stamped)

EPA Form 8570-1 (Rev. 3-94) Previous editions are obsolete. White - EPA File Copy (original) Yellow

[Wex-Cide][CONCENTRATED GERMICIDAL DETERGENT]

[Whirlpool Pedicure Spa Disinfectant]CLEANS • DISINFECTS • DEODORIZES

GERMICIDAL, PSEUDOMONACIDAL, TUBERCULOCIDAL, FUNGICIDAL andVIRUCIDAL*

[For use in Whirlpool baths, Foot Spas, Beauty Salons, Barber shops andHospitals]

In soft or hard water (A.O.A.C. 400 ppm hardness as calcium carbonate)

ACTIVE INGREDIENTS:ortho-Phenylphenol 6.74%ortho-Benzyl-para-Chlorophenol 5.76%INERT INGREDIENTS: 87.50%

100.00%

KEEP OUT OF REACH OF CHILDRENDANGER

See side panel for additional precautionary statements

[Wex-Cide]• [Is to clean and disinfect washable hard nonporous surfaces of: whirlpool

baths, foot spas, salon/barber tools and instruments: combs, brushes,and manicure instruments.]

• [Meets AOAC efficacy standards for hospital disinfectants.]• [Is a proven disinfectant - cleaner - fungicide - tuberculocide - virucide*

which is effective in soft or hard water up to 400 ppm

[PREPARATION OF DISINFECTANT USE-SOLUTION: ADD (MIX) 1/2 OZ. PER GALLON OFWATER)

Wexford Labs, Inc.325 Leffingwell AvenueKirkwood, Missouri 63122

EPA Reg. No. 34810-8 EPA Est. No. [Insert Est. No. here]

FOR INDUSTRIAL AND INSTITUTIONAL USEContents: One U.S. Gallon (128 Fluid Ounces) or 3.785 Liters

GERMICIDAL OR [BACTERIACIDAL] QUALIFICATIONS:(AOAC Use Dilution Confirmation) in the presence of 400 ppm hardness as CalciumCarbonate 1:256(AOAC Ps. aeruginosa, S. aureus, S.enterica including methicillin resistant S.aureus[MRSA] and S. Epidermidis [MRSE], Enterococcus faecalis [VRE]).TUBERCULOCIDAL ACTIVITY:(AOAC M. tuberculosis) in the presence of 400 ppm hardness as Calcium Carbonate 5%(at 20° C for 10 minutes) 1:256FUNGICIDAL TEST:(AOAC T. Mentagrophytes) in the presence of 400 ppm hardness as Calcium Carbonateand 5% serum at 1:256VIRUCIDAL ACTIVITY TEST:('Influenza A3 virus [Hong Kong], Pandemic 2009 H1N1 Influenza A Virus (formerly

called Swine Flu), Adenovirus Type 2, Herpes simplex virus Types 1 and 2, Vacciniavirus, Human Rotavirus, and Respiratory Syncytial virus in the presence of 400 ppmhardness and 5% serum, and HIV-1 [AIDS]) in the presence of 400 ppm hardness asCalcium Carbonate and 10% serum at 1:256

PRECAUTIONARY STATEMENTSHAZARD TO HUMANS AND DOMESTIC ANIMALS. DANGER. Corrosive.Causes irreversible eye damage. Harmful if inhaled or swallowed. Do not get ineyes, on skin, or on clothing. Wear goggles or face shield and chemicalresistant gloves. Wash thoroughly with soap and water after handling andbefore eating, drinking, chewing gum, using tobacco or using the toilet. Avoidbreathing spray mist. Remove and wash contaminated clothing before reuse.FIRST AID: IF IN EYES - hold eye open and rinse slowly and gently with waterfor 15-20 minutes. Remove contact lenses, if present, after the first 5 minutes,then continue rinsing. Call a poison control center or doctor for treatmentadvice. IF ON SKIN OR CLOTHING - take off contaminated clothing. Rinseskin immediately with plenty of water for 15-20 minutes. Call a poison controlcenter or doctor for treatment advice. IF INHALED - move person to fresh air.If person is not breathing, call 911 or an ambulance, then give artificialrespiration preferably mouth-to-mouth if possible. Call a poison control center ordoctor for further treatment advice. IF SWALLOWED - call a poison controlcenter or doctor immediately for treatment advice. Have person sip a glass ofwater if able to swallow. Do not induce vomiting unless told by a Poison ControlCenter or doctor. Do not give anything by mouth to an unconscious person.HOT LINE NUMBER: In case of an emergency call toll free 1- (800) 424-9300.Have the product container or label with you when calling a poison controlcenter or doctor or going for treatment. NOTE TO PHYSICIAN: Probablemucosal damage may contraindicate the use of gastric lavage. Measuresagainst circulatory shock, respiratory depression and convulsion may beneeded.

Made in U.S.A.

Note to reviewer: Language in [ ] is optional or interchangeable

[Wex-Cide][CONCENTRATED GERMICIDAL DETERGENT]

DIRECTIONS FOR USE: It is a violation of Federal Law to use this product in amanner inconsistent with its labeling. DO NOT MIX WITH OTHER CLEANERS. Forall disinfection of hard surfaces in hospitals, health-care facilities, schools andnursing homes, use this product at a dilution of 1/2 ounce per gallon of water forwalls, floors, bathroom fixtures, stainless steel, chrome, glass and vinyl.

[AREAS OF USE:1[Hospitals][Health Care Facilities][Medical Offices][Dental offices][Day care centers][Nurseries][Nursing homes][Institutions][Institutional facilities][Barber Shops]

[Schools][Bathrooms][Whirlpool (baths) (units)][Turkey farms][Poultry farms][Zoos][Foot spas][Salons (Beauty)][Whirlpool pedicure spa]

fTYPES OF SURFACES:][On washable hard, nonporous surfaces of:][Bathroom fixtures][Floors][Walls][Stainless Steel][Chrome][Glass][Vinyl]

Surface Cleaning: Prior to surface disinfection, pre-clean surfaces, makingsure to remove all gross filth and heavy soil, by saturating surfaces with[this product] use solution and allowing surfaces to remain wet for 15seconds; then wipe clean.[This product's] solution may be applied with a cloth, mop or brush, or byimmersing equipment to be disinfected. Wet all surfaces thoroughly. Thesurface must remain wet for at least 10 minutes and allowed to air dry.Gross filth and heavy soil must be removed before applying cleaningsolution. When used for mopping or from an open pail, solution should bechanged at least daily or more often if the solution becomes diluted orsoiled. [This product] is suitable for cleaning floors and walls in thedepartments of food processing plants at 1:256 use dilution.

[DILUTION: 1:256 1/2 oz. per gallon of water1. Remove all animals and feeds from premises, trucks, coops, crates, and enclosures.2. Remove all litter and manure from floors, walls, and surfaces of barns, pens, stalls,

chutes, vehicles, and other facilities and fixtures occupied or traversed by animals.3. Empty all troughs, racks, and other feeding and watering appliances.4. Thoroughly clean all surfaces with soap or detergent, and rinse with water.5. Saturate all surfaces with the disinfecting solution for a period of 10 minutes.6. Immerse all halters, ropes, and other types of equipment used in handling and

restraining animals, as well as forks, shovels, and scrapers used for removing litterand manure.

7. Ventilate buildings, coops, cars, trucks, boats, and other closed spaces. Do not houseanimals or employ equipment until treatment has been absorbed, set, or dried.

8. After treatment with disinfectant, thoroughly scrub feed racks, troughs, automaticfeeders, fountains, and waterers with soap or detergent, and rinse with potable waterbefore reuse.]

[This product at 1/2 oz. per gallon of water (1:256) is suited for disinfecting and cleaning inpoultry and turkey barns, breeder and laying operations.]

[Poultry house grow-out operations and hatcheries: Use in hatchers and setters, evaporativecoolers, humidifying systems and ceiling fans, live haul equipment, chick busses, transfer trucks,trays, coop washing, polyethylene chick boxes, foot pans and feed bins.]

[Equine facilities: Use in stables, stalls, breeding and foaling areas and transport vehicles.]

[SALON/BARBER INSTRUMENTS AND TOOLS DISINFECTION BACTERICIDE / VIRUCIDE/FUNGICIDE DIRECTIONS:Pre-clean surfaces prior to surface disinfection.Mix 1/2 oz. (15 ml) of [this product] per gallon of water or 0.125 oz (3.75 ml) of this product perquart of water to disinfect hard, nonporous instruments and tools. Completely immerse combs,brushes, rollers, manicure and other salon instruments and tools for 10 minutes. For heavily soiledinstruments and tools, a preliminary cleaning is required. Rinse thoroughly and dry before use.Fresh solution should be prepared daily or more often if solution becomes diluted or soiled.Note: Plastics may remain immersed until ready to use. Stainless steel instruments must beremoved after 10 minutes, rinsed, dried, and kept in a clean non-contaminated receptacle.Prolonged soaking may cause damage to metal instruments.]

[WHIRLPOOL FOOT SPA DISINFECTION:Pre-clean surfaces prior to surface disinfection.

After using whirlpool foot spa, drain the water. Use 1/2 oz. of [this product] per gallonof water to cover intake valve. Start pump to circulate the solution. Swab exposedsurfaces including unit sides, chairs, and any related equipment thoroughly with cloth,sponge, or brush and allow treated surfaces and solution to stand for 10 minutes. Afterunit has been thoroughly disinfected, rinse all disinfected surfaces with fresh water. ]

[FARM PREMISE, LIVESTOCK, POULTRY & TURKEY HOUSEDISINFECTANT]

Note to reviewer: Language in [ ] is optional or interchangeable

[DISINFECTION OF [WHIRLPOOL (BATH(S) (UNITS)]:Pre-clean surfaces prior to surface disinfection.After using the [whirlpool (bath) (unit)], drain and refill with fresh water to(just cover the intake valve) (cover the highest jet) (2 inches above thehighest jet). Add % ounce of [this product] for each gallon of fresh wateradded. Start the pump to circulate the solution. Wash down [the (deck)(seat of chair) (any related equipment)] any uncovered surfaces on the(bath) (unit) with a clean swab, brush or sponge with the solution. Treatedsurfaces must remain wet for 10 minutes. After the (bath) (unit) has beenthoroughly disinfected, drain and rinse surfaces with fresh water. Wipedry with a clean sponge or cloth or allow to air dry. Repeat for heavilysoiled units.]

DECONTAMINATION OF CRITICAL OR SEMI-CRITICAL DEVICESPRIOR TO TERMINAL STERILIZATIONS/HIGH LEVEL DISINFECTION:This product is not to be used as a terminal sterilant/high level disinfectanton any surface or instrument that (1) is introduced directly into the humanbody, either into or in contact with the bloodstream or normally sterileareas of the body, or (2) contacts intact mucous membranes, but whichdoes not ordinarily penetrate the blood barrier or otherwise enter normallysterile areas of the body. This product may be used to preclean ordecontaminate critical or semi-critical medical devices prior to sterilizationor high level disinfection.

•[THIS PRODUCT] KILLS HIV ON PRE-CLEANED ENVIRONMENTALSURFACES/OBJECTS PREVIOUSLY SOILED WITH BLOOD/BODYFLUIDS in health care settings or other settings in which there is anexpected likelihood of soiling of inanimate surfaces/objects with blood orbody fluids, and in which the surfaces/objects likely to be soiled withblood or body fluids can be associated with the potential fortransmission of human immunodeficiency virus type 1 (HIV-1)(associated with AIDS).SPECIAL INSTRUCTIONS FOR CLEANING ANDDECONTAMINATING SURFACES/OBJECTS SOILED WITH BLOODAND BODY FLUIDS WHICH MAY CONTAIN HIV-1 (AIDS virus).PERSONAL PROTECTION: Wear disposable rubber or latex gloves,gowns, face masks and eye coverings as appropriate, when performingmanual cleaning of these surfaces.CONTACT TIME: Leave surfaces wet for 1 minute. This contact timewill not control other common types of viruses and bacteria.CLEANING PROCEDURE: [THIS PRODUCT] solution may be used toremove and clean blood and other body fluids from surfaces and objectsbefore disinfection. For lightly soiled areas wipe off visual soil/cleanwith [THIS PRODUCT] solution, and disinfect surface with a secondapplication of the [THIS PRODUCT] solution. For large spills thecontaminated area should be flooded with the [THIS PRODUCT]solution before cleaning, then decontaminated with fresh [THISPRODUCT] solution.

DISPOSAL OF INFECTIOUS MATERIAL: Blood and other body fluids should beautoclaved and disposed of according to Federal, State and local regulations forinfectious waste disposal.

STORAGE AND DISPOSALDo not contaminate water, food, or feed by storage or disposal.

PESTICIDE STORAGE: Keep upright with cap tightly closed. Store in originalcontainer in areas inaccessible to children.PESTICIDE DISPOSAL: Pesticide wastes are acutely hazardous. Improper disposalof excess pesticide, spray mixture or rinsate is a violation of Federal Law. If thesewastes cannot be disposed of by use according to label instructions, contact yourState Pesticide or Environmental Control Agency, or the Hazardous WasteRepresentative at the nearest EPA Regional Office for guidance.CONTAINER HANDLING: Nonrefillable container. Do not reuse or refill thiscontainer. Clean container promptly after emptying. Triple rinse as follows: Empty theremaining contents into application equipment or a mix tank and drain for 10 secondsafter the flow begins to drip. Fill the container % full with water and recap. Shake for10 seconds. Pour rinsate into application equipment or a mix tank or store rinsate forlater use or disposal. Drain for 10 seconds after the flow begins to drip. Repeat thisprocedure two more times. Then offer for recycling if available, or puncture anddispose of in a sanitary landfill or by incineration. Do not burn unless allowed by stateand local ordinances.

062011[Packaged by:][Lighthouse for the Blind][St. Louis, MO 63132-1209][800-542-3697]

[Produced with Pride by Americans Who are Blind.][Skilcraft is a registered trademark, licensed by National Industries for the Blind.]

Note to reviewer: Language in [ ] is optional or interchangeable